Identifying and Managing Hazardous Pharmaceutical Waste

H2E TeleconferenceSeptember 12, 2003

Charlotte A. Smith, R. Ph., M.S.President

csmith@ pharmecology.com

www.pharmecology.com

262-814-2635

Copyright © 2003 by PharmEcology Associates, LLC

Pharmaceutical Waste: A Waste Stream Whose

Time has ComeConcept of “Green Pharmacy” Gaining Attention "Cradle-to-Cradle Stewardship of Drugs for

Minimizing Their Environmental Disposition While Promoting Human Health.”

Dr. Christian Daughton, Chief, Environmental Chemistry Branch, USEPA National Exposure Research Laboratory

I. Rationale for and Avenues toward a Green Pharmacy;

II. Drug Disposal, Waste Reduction, and Future Directions,

http://www.h2e-online.org/tools/chem-pharm.htm

Increasing Regulatory Activity EPA Region 2 auditing 480 hospitals in 2003; Rx waste

included; link from H2E to Region 2 website http://www.h2e-online.org/tools/chem-hwm.htm

States beginning to focus on management of waste pharmaceuticals

Florida Washington State California Minnesota Michigan

Intersecting regulatory agencies EPA, DEA, OSHA, State Boards of

Pharmacy

H2E and Hazardous Pharmaceuticals

Initial involvement while at Capital Returns, Inc., Rx reverse distributor, 1999-2000

Worked on Chemical Minimization Committee with Catherine Zimmer, Minnesota Technical Assistance Program (MnTAP)

http://www.h2e-online.org/pubs/chemmin/pharmacy.pdf Contributed to prioritization tool by reviewing all drug

products in CRI database http://www.h2e-online.org/pubs/chemmin/chappf.pdf

USGS Water Quality Study*First nationwide reconnaissance of occurrence of

pharmaceuticals, hormones, other organic wastewater contaminants

139 streams in 30 states, analyzed for 95 different OWCs

82 of the 95 detected in at least one sampleOne or more OWCs found in 80% of stream

samples13% of sites had more than 20 OWCs*http://toxics.usgs.gov/pubs/OFR-02-94/index.html

Below the Dose/Response Curve:Endocrine Disruptors

Endocrine Disruptors: chemicals that interfere with the normal function of the endocrine system (glands including thyroid, adrenals, ovaries, testicles)

Mimic hormone, trigger identical response, block a hormone

Do not follow the normal dose/response curve Active at much lower doses, especially in the fetus and

newborn Estradiols, progesterone, testosterone Lindane

Low sperm counts(50% reduction since 1939) InfertilityGenital deformitiesHormonally triggered human cancersNeurological disorders in children

Hyperactivity Attention deficit

Developmental & reproductive problems in wildlife

Pharmaceuticals Enteringthe Waste Stream

Wastage of Raw Materials from Manufacturing Process

Wastage at the Distributor/ Pharmacy/Healthcare Facility

Wastage at the LTCF or other residential facility

Expired PharmaceuticalsWastage at the Consumer LevelMetabolites Entering Wastewater

When is an Outdated Drug a Waste?

At the time and place the decision is made to discard it

Two EPA guidance letters to the industry: Merck & Co., 1981 BFI Pharmaceutical, 1991

Enables shipping of potentially creditable outdates to a reverse distributor as product

PROHIBITS the shipping of waste-like items, such as unused IVs, partial vials

Reverse Distribution: Current Scenarios

Decision to discard is made at the pharmacy By pharmacy By a contracted company Pharmacy (hospital) becomes the waste

generator

Decision to discard is made at the reverse distributor Reverse Distributor becomes the waste

generator

Where Have Waste Drugs Gone in the Past?

Primarily concerned with rendering drugs unrecoverable Not in dumpsters, municipal trash Made slurries, sewered Burned in hospital incinerators

No training in pharmacy curriculum on EPA regulations

Where are Waste Drugs Going Today?

Sewer System Unused, partial IVs, including antibiotics Compounding residues Liquids

Red Infectious Waste Sharps Containers, Bags

Yellow or White Chemotherapy Sharps Containers, Bags

MUNICIPAL WASTE SEWER SYSTEMCHEMO WASTE

- SHARPSCHEMO WASTE

- SOFT RED SHARPS

• Packaging• Empty glass bottles• Empty plastic bottles• Paper• Plastic• Food waste, etc.

• IV’s- D5W- NaCl- Other?

• Controlled substances?• Antibiotics?

• Vials - Empty (trace)

- Partial (residue)• Syringes/Needles - Empty

- Unused, partial• IV’s - Empty - Unused, partial• Spill clean up?

• Gowns• Gloves• Goggles• Tubing• Wipes• Spill clean up?

• Vials - Empty - Partial• Syringes/Needles - Empty - Unused, partial• IV’s - Empty - Unused, partial

LANDFILL ORMUNICIPAL INCINERATOR

WATER TREATMENT PLANT

Leachate into ground water or

air emissions

Discharge to surface waters

Leachate

Contents of Current Pharmaceutical Waste Streams

Copyright © 2002 by PharmEcology™ Associates, LLC

AUTOCLAVE/MICROWAVE

Shredded (?)

NON-HAZARDOUS LANDFILL

Ash

MEDICAL WASTE INCINERATOR

How is Pharmaceutical Waste Generated at the Healthcare Facility?

IV PreparationGeneral CompoundingSpills/BreakagePartially Used Vials/Syringes

If Contaminated, BiohazardousDiscontinued, Unused PreparationsUnused Repacks (Unit Dose)Discontinued Indated PharmaceuticalsPatients’ Personal MedicationsOutdated Pharmaceuticals

Where is Pharmaceutical Waste Generated?

Pharmacy/SatellitesPatient Care UnitsER/OR ICU/CCU/NICUOncology/Hematology and other outpatient clinicsLong Term Care FacilitiesHome Health Care Services

What Departments Get Involved in Generating and Managing

Pharmaceutical Waste?

PharmacyNursing Infection ControlEnvironmental ServicesSafetyFacility ManagementRisk ManagementPurchasing

Federal Waste Generation Status

Large Quantity Generator (LQG): generates more than 1000 kg/month of hazardous waste or >1 kg/month “P” listed waste.

Small Quantity Generator (SQG):Generates <1000 kg/month but >100 kg/month of hazardous waste & < or = 1 kg/month “P” listed waste.

Conditionally Exempt Small Quantity Generator (CESQG):Generates < or = 100 kg haz waste/month, < or = 1kg P listed waste/month

Which Discarded Drugs Become Hazardous Waste?

P-listed chemicals Sole active ingredient

U-listed chemicals Sole active ingredient

Characteristic of hazardous waste Ignitability Toxicity Corrosivity Reactivity

Examples of P-Listed Pharmaceutical Waste

Arsenic trioxide P012Epinephrine P042Nicotine P075Nitroglycerin P081Phentermine (CIV) P046Physostigmine P204Physostigmine Salicylate P188Warfarin >0.3% P001

Examples of P-Listed Pharmaceuticals

Impact of P-listed Waste

Only 1 kg or 2.2 pounds/month cause facility to become a large quantity generator

Weights of P-listed drug waste must be combined with any other P-listed waste generated at the facility in a given month

Technically, containers that have held P-listed wastes are not “RCRA empty” unless they are triple rinsed and the rinsate discarded as hazardous

Examples of U-listed Pharmaceutical Waste

Chloral Hydrate(CIV) U034

Chlorambucil U035

Cyclophosphamide

U058

Daunomycin U059

Melphalan

U150

Mitomycin C U010

Streptozotocin U206

Lindane U129

Saccharin U202

Selenium Sulfide U205

Uracil Mustard U237

Warfarin<0.3% U248

Examples of U-Listed

Pharmaceuticals

Chemotherapy WasteSeven chemotherapy agents are U-listed; one is P-

listedMedical waste hauler protocols for “Chemo

Waste” Empty vials, syringes, IV’s Treated as infectious medical waste preferably through

regulated medical waste incineration If not empty, should be placed into Hazardous

Waste container“Empty” for U-listed waste means all contents

removed that can be removed through normal means

3 ml allowance in common practice is a misunderstanding of the definition of “RCRA empty”

Chemotherapy Residue: Infectious and Hazardous

If chemo IV bag has been hung, is not completely used and can be separated from patient exposed sharp without exposing the employee, remove and dispose as RCRA hazardous waste

If chemo residue cannot be removed safely, dispose in trace chemotherapy container (yellow/white) as infectious chemo waste

No consensus yet on this issue among hazardous waste regulators

Empty vials, syringes, IVs,

tubing, gowns, gloves,etc.

Residue or bulk chemoin vials, unused IV’s, P, U. toxic D

Chemo Waste Hazardous Waste

Characteristic of IgnitabilityAqueous Solution

containing 24% alcohol or more by volume & flash point<140° F.

Hazardous Waste Number: D001

Rubbing AlcoholTopical Preparation Injections

Characteristic of Corrosivity

An aqueous solution having a pH < or = 2 or > or = to 12.5

Examples: Primarily compounding chemicals Glacial Acetic Acid Sodium Hydroxide

Hazardous waste number: D002

Characteristic of Toxicity

Approximately 40 chemicals which meet specific leaching concentrations

Examples of potential toxic pharmaceuticals:Arsenic m-CresolBarium Mercury (thimerosal)Cadmium phenylmercuric acetate)Chloroform Selenium Chromium SilverLindane

Preservatives: thimerosal & m-cresol

Heavy Metals: Selenium, Chromium and Silver

Examples of Pharmaceuticals Exhibiting the Characteristic of

Toxicity

Characteristic of Reactivity

Meet eight separate criteria identifying certain explosive and water reactive wastes

Nitroglycerin formulations may be considered exempt as of August 14, 2001 under FR: May 16, 2001. States must still adopt.

Hazardous Waste Number: D003

How Can RCRA Hazardous Waste be Identified?

Web-based database enabling search by product for waste management recommendations

Search by NDC, product or generic name, active ingredient Recommendations citing federal regulations and

recommended waste streams State regulation alerts if more stringent than federal Risk Management alerts based on professional

knowledge (e.g. chemotherapy agents not regulated at the state or federal level)

Readi-Cat

How Should RCRA Hazardous Waste be Handled?

Need a new waste stream in Pharmacy, certain Patient Care Areas, Oncology Clinics

RCRA Hazardous Waste: Toxic P, U, toxic Ds, all Chemotherapy Residues,

Chemo Spills RCRA Hazardous Waste: Ignitable (D001) Hospitec has developed a dedicated hazardous waste

containment system Can also use hazardous waste buckets available from

brokers and disposal firms

Recommended Additional Pharmaceutical Waste Streams

HAZARDOUS WASTE - IGNITABLE

HAZARDOUS WASTE - TOXIC NON-HAZARDOUS

NON-INFECTIOUS RX

FEDERALLY PERMITTED HAZARDOUS WASTE INCINERATOR (HIGH TEMPERATURE, SCRUBBERS)

LINED HAZARDOUS WASTE LANDFILL

Hazardous waste broker and transporter

Ash

NON-HAZARDOUS LANDFILL

MEDICAL WASTE

INCINERATOR

Ash

Copyright © 2002 by PharmEcology™ Associates, LLC

Leachate

MUNICIPAL INCINERATORPERMITTED

FOR SPECIAL WASTE

Ash

MUNICIPAL

• Packaging• Empty bottles• Paper• Plastic• Food waste, etc.

• Gowns• Gloves• Goggles• Tubing• Wipes

• Vials - Empty• Syringes/Needles - Empty• IV’s - Empty

Recommended Revised Pharmaceutical Waste Streams

Copyright © 2002 by PharmEcology™ Associates, LLC

SEWER SYSTEM

• Recycle as much paper, glass, plastic as possible

• Use shredder where patient privacy is an

issue

HAZARDOUS WASTE - TOXIC

HAZARDOUS WASTE

- IGNITABLE

CHEMO WASTE- SOFT

CHEMO WASTE

- SHARPS

NON-HAZARDOUS

RX

RED SHARPS

• IV’s - D5W

- NaCl• Controlled Substances?• Antibiotics?

• P-listed• U-listed• D-listed toxic (Heavy metals)• Chemo agents (residue, bulk)• Chemo spill clean up• Hazardous spill clean up• Risk management: - Antivirals - Others

• D-listed Ignitable- Collodion- Oxidizers- Ignitable

compressed gas

All waste pharmaceuticals NOT hazardousincludingantibiotics, IV’s

• Non-chemo vials - Empty• Non-chemo syringes/ needles - Empty

• Check withmunicipal water treatment plant

for limits, recommendations

NON-HAZARDOUS LANDFILL

Leachate

MUNICIPAL INCINERATORPERMITTED

FOR SPECIAL WASTE

AUTOCLAVE/MICROWAVE

Shredded (?)

MEDICAL WASTE INCINERATOR

AshAsh

FEDERALLY PERMITTED HAZARDOUS WASTE INCINERATOR (HIGH

TEMPERATURE, SCRUBBERS)

LINED HAZARDOUS WASTE LANDFILL

Ash

Where Should RCRA Hazardous Waste Be Stored?

Hazardous Waste Storage Accumulation Site:

Same locked area as mercury, xylene, formaldehyde, lab chemicals

Maximum storage time: 90 or 180 days based on generator status

Yellow Hazardous

Waste Label

How Should RCRA Hazardous Waste Be Disposed?

Either contract with a hazardous waste broker or develop internal expertise for: Lab packing Manifest preparation Land ban preparation

Contract with a federally permitted RCRA hazardous waste incineration facility (TSDF: Treatment, Storage & Disposal Facility)

How Can Hazardous RX Waste Generation Be Minimized?

Inherent limitations on substitution of a less hazardous drug since the hazardous nature of the chemical often provides the therapeutic effect

Tighter inventory control to reduce outdate generation, both original manufacturers’ containers and repacks

Single dose vials vs. multiple dose vialsPatient specific oral syringes vs. 10 cc. repacks

(e.g. choral hydrate for pediatric use)Reformulation of heavy metal concentration,

especially mercury and m-cresol as preservatives

What About Non-Hazardous Drugs?

Segregate into a non-red, non-yellow container, such as beige or white with blue top (California Pharmaceutical Waste)

Label “Non-hazardous Pharmaceutical Waste – Incinerate Only”

Dispose at a regulated medical waste or municipal incinerator that is permitted to accept non-hazardous pharmaceutical waste

Where to Begin?

Purchase appropriate containers for collecting toxic and ignitable hazardous waste

Pilot bulk and residue chemotherapy segregation in the pharmacy and on the oncology unit

Extend the program to all units that handle any chemotherapy agents (methotrexate and cyclophosphamide used in other units)

Begin identifying other P, U and D hazardous wastesTrain all relevant staff on the reasons for the new

system

Jump-Starting the ProcessElectronic formulary review service

Send PharmEcology Associates your drug formulary information

We compare it to our database of over 107,000 drug items

You receive back a list of which drugs are hazardous waste or risk management hazardous waste

On-site review A one or two day visit to your facility followed by an

Action Plan and Findings and Recommendations

Benefits of a Comprehensive Hazardous Waste Disposal Plan

JCAHO Environment of Care Performance Improvement Initiative New 2004 Standards – see both Medication

Management and Environment of CareReduces EPA liability and risk exposure to a

minimumProtects employees and patientsDemonstrates responsible care in dealing with

hazardous substances, hazardous wastes

Resources www.pharmecology.com Pharmaceutical Waste:

http://www.h2e-online.org/tools/chem-pharm.htm “Safely Managing Hazardous Materials and Hazardous

Waste,” ASHP Clinical Midyear, 2001, Handouts on CD-Rom

RCRA On-Line www.epa.gov/rcraonline RCRA Hot Line 1-800-424-9346 Improper Discard of Toxic Drugs Hurts Environment,

Leads to Fines, AJHP, Vol 58, #17 September 1, 2001 pp 1576-1578.

Resources Pharmaceutical Waste Survey, King County, Washington

State, April 29, 2003, http://www.metrokc.gov/hazwaste/pubs/studies.html#pharmwastesurvey

Your Risks in Handling Outdated and Unusable Drugs: A Guide to JCAHO and Regulatory Standards. Capital Returns, Inc., 1998 Call 1-800-950-5479

A Guide on Hazardous Waste Management for Florida’s Pharmacies, www. floridacenter.org.

Guidelines for Reverse Distributors: Minimum Federal Regulatory Standards, www.returnsindustry.com